IMR Press / FBE / Volume 5 / Issue 1 / DOI: 10.2741/E621

Frontiers in Bioscience-Elite (FBE) is published by IMR Press from Volume 13 Issue 2 (2021). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement with Frontiers in Bioscience.

Open Access Review

Legal issues for chem-bioinformatics models

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1 Department of Especial Public Law, Financial and Tributary Law Area,Faculty of Law, University of Santiago de Compostela (USC), 15782, Santiago de Compostela, Spain
2 Department of Microbiology and Parasitology, Faculty of Pharmacy, USC, 15782, Santiago de Compostela, Spain

*Author to whom correspondence should be addressed.

Front. Biosci. (Elite Ed) 2013, 5(1), 361–374; https://doi.org/10.2741/E621
Published: 1 January 2013
Abstract

Chem-Bioinformatic models connect the chemical structure of drugs and/or targets (protein, gen, RNA, microorganism, tissue, disease…) with drug biological activity over this target. On the other hand, a systematic judicial framework is needed to provide appropriate and relevant guidance for addressing various computing techniques as applied to scientific research in biosciences frontiers. This article reviews both: the use of the predictions made with models for regulatory purposes and how to protect (in legal terms) the models of molecular systems per se, and the software used to seek them. First we review: i) models as a tool for regulatory purposes, ii) Organizations Involved with Validation of models, iii) Regulatory Guidelines and Documents for models, iv) Models for Human Health and Environmental Endpoint, and v) Difficulties to Validation of models, and other issues. Next, we focused on the legal protection of models and software; including: a short summary of topics, and methods for legal protection of computer software. We close the review with a section that treats the taxes in software use.

Keywords
Bioinformatics
Legal issues
QSAR model
QSPR model
Software copyright
OECD
REACH
New laws of registration
Evaluation
Authorization of Chemicals
Review
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